BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1813000 · Received August 6, 2010

    Report

    Report Number
    3005075853-2010-04480
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 15, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. THE DEVICE WOULD FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOR THE EL5ML DEVICE (B) FOUND THAT IT WAS RETURNED WITH THE SHAFT BENT AT THE MIDDLE. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE RETURNED CONDITION OF THE DEVICE. POSSIBLE CAUSES FOR THE DAMAGE FOUND MAY BE INADVERTENT PRESSURE PLACED ON THE DEVICE SHAFT. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. (B)(4), EXPIRATION DATE: 01/2015. MANUFACTURING DATE: (B)(4) 2010. DAMAGED SHAFT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, BOTH DEVICES WOULD NOT RELEASE AT FIRST, EVENTUALLY THE DEVICES RELEASE WHEN THE SURGEON PULLED ON THE HANDLE. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC NA G4RF7R

    Patients

    Seq Age Sex Outcome Treatment
    1